High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in
This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy an
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy and they will undergo the study imaging preoperatively. The second group experiences biochemical relapse after primary treatment. |
| Who can participate | Inclusion criteria Work-unit 1 * age \< 75 years of age, with histologically proven invasive adenocarcinoma of the prostate * a risk of equal or more than 5% of lymph node metastasis (intermediate to high risk disease), according to the Briganti nomogram (1) * scheduled to undergo radical prostatectomy with extended lymph node dissection Work-unit 2 * histologically proven diagnosis of prostate cancer * biochemical relapse (two consecutive PSA≥0.2 ng/ml) of prostate cancer following radical local prostate treatment * WHO performance state 0-1 * age \> 18 years old Exclusion criteria Work-unit 1 * involvement of pelvic lymph nodes assessed by multi-parametric MRI * evidence for bone metastasis assessed by bone scan (if PSA \> 20 ng/ml) * WHO performance status \> 2 * previous pelvic irradia |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Locations | Leuven, Belgium |
| Start date | 2017-09-22 |
| NCT ID | NCT03327675 |
| Official listing | https://clinicaltrials.gov/study/NCT03327675 |